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Effect of an Early and Intensified Nutritional Intervention on the Risk of Developing Gestational Diabetes Mellitus (MedDiet in GDM)

12 septembre 2026 mis à jour par: Ana M. Ramos-Leví, Hospital San Carlos, Madrid

Effect of an Early and Intensified Nutritional Intervention Based on a Mediterranean Diet (MedDiet) in Women With Clinical-genetic Risk of Developing Gestational Diabetes Mellitus (GDM): a Randomized, Parallel, Interventional, Controlled Clinical Trial

The goal of this clinical trial is to learn if a nutritional intervention based on a Mediterranean diet (MedDiet), initiated early in pregnancy, reduces the incidence of gestational diabetes mellitus (GDM) and other adverse maternal, fetal and obstetric events in pregnant women considered high-risk. It will also learn about the stratification of GDM risk based on clinical, anthropometric, analytical and genetic characteristics.

The main questions it aims to answer are:

  • Does the nutritional intervention based on MedDiet reduce the incidence of GDM in women with high risk?
  • How can we stratify the risk of GDM? Researchers will compare an advanced nutritional intervention based on a Mediterranean diet to standard care (general recommendations given at the beginning of pregnancy).

Participants will:

  • Receive intensive nutritional counselling or standard regular recommendations during the first trimester of pregnancy.
  • Visit the clinic at the time of the first ultrasound (gestational week 8-11) and at the time of screening for GDM (gestational week 24-26).
  • Undergo a genetic test performed with a buccal swab.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

1200

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Espagne
    • Madrid
      • Madrid, Madrid, Espagne, 28040
        • Hospital Clinico San Carlos
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Unassisted single pregnancy;
  • Age between 18 and 50 years old;
  • Fasting blood glucose <92 mg/dl in the first gestational blood test;
  • First trimester ultrasound before the 12th gestational week.

Exclusion Criteria:

  • Multiple or assisted pregnancies;
  • Any pregestational illness or pregestational treatment that may affect pregnancy;
  • Known intolerance/allergy to any component of the nutritional intervention.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Standard treatment
The nutritional intervention will consist of providing information on healthy lifestyle measures through an 8-minute informational video (accessible via QR code at the consultation room or the permanent link https://www.youtube.com/watch?v=Qgcz5t9B9WI). Routine obstetric follow-up does not involve subsequent monitoring of adherence to these recommendations, beyond the usual follow-up.
Expérimental: Advanced treatment
A specific nutritional intervention consisting of a group session that will last approximately one hour, led by a nutritionist from the research team. This session will explain in detail the key aspects of the MedDiet: consumption of >40 ml/day of extra virgin olive oil, 30 g of nuts per day, 3-4 pieces of whole fruit (not juice), homemade stir-fries, 2-3 servings of vegetables and/or salads per day, 2-3 servings per day of low-fat dairy products, whole grains, 2-3 servings of legumes per week, consumption of fish, limiting the consumption of red meat, and avoiding ultra-processed products, sliced bread, soft drinks, juices, fast food, and pre-cooked products. Two telephonic interviews will be scheduled for follow-up around gestational weeks 16 and 20 to provide motivation and assess and reinforce adherence to these recommendations.
Autre: Nutritional intervention based on a Mediterranean diet
The nutritional intervention consists of a 1-hour group session led by a nutritionist from the research team. Includes a detailed description of the key aspects of the MedDiet: consumption of >40 ml/day of extra virgin olive oil, 30 g of nuts per day, 3-4 pieces of whole fruit (not juice), homemade stir-fries, 2-3 servings of vegetables and/or salads per day, 2-3 servings per day of low-fat dairy products, whole grains, 2-3 servings of legumes per week, consumption of fish, limiting the consumption of red meat, and avoiding ultra-processed products, sliced bread, soft drinks, juices, fast food, and pre-cooked products. In addition, 2 telephonic interviews for follow-up (gestational weeks 16 and 20) to reinforce adherence and emphasize consumption of >40 ml/day of extra virgin olive oil, 30 g of nuts per day, 3-4 pieces of whole fruit (not juice), daily vegetables and daily physical activity.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of gestational diabetes mellitus
Délai: From enrollment (gestational week 8-11) to the time of screening for gestational diabetes mellitus (gestational week 24-26)

The general objective of this study is to determine whether an advanced nutritional intervention based on Mediterranean diet reduces the incidence of gestational diabetes mellitus and other adverse maternal-fetal obstetric and endocrine-metabolic events in pregnant women considered high-risk based on a risk score derived from the interaction between associated genetic polymorphisms, baseline clinical characteristics, and anthropometric characteristics of pregnant women.

The primary outcome is the comparison of the frequency of GDM, according to IADPSG criteria, between the MedDiet intervention group and the standard treatment group in women at high risk according to the calculated risk of developing GDM.
From enrollment (gestational week 8-11) to the time of screening for gestational diabetes mellitus (gestational week 24-26)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Frequency of maternal complications
Délai: From enrollment (gestational week 8-11) to delivery
Frequency of maternal complications between the MedDiet intervention group and the standard treatment group in women at high risk according to the calculated risk of developing GDM. Variables for this outcome include: maternal weight, weight gain; risk score; frequency of maternal complications (hypertension, eclampsia, infections, carbohydrate metabolism disorders - defined as alterations in normal levels of at least one of the following: fasting glucose, HbA1c, C-peptide, insulin, HOMA-IR)
From enrollment (gestational week 8-11) to delivery
Frequency of fetal complications
Délai: From enrollment (gestational week 8-11) to delivery and neonatal period
Comparison of the frequency of fetal complications between the MedDiet intervention group and the standard treatment group in high-risk women, based on the calculated risk of developing gestational diabetes mellitus (GDM). Variables for this outcome include: birth weight, hypoglycemia, potassium abnormalities, calcium abnormalities, polycythemia, admission to the neonatal intensive care unit (NICU).
From enrollment (gestational week 8-11) to delivery and neonatal period
Frequency of obstetric complications
Délai: From enrollment (gestational week 8-11) to delivery and immediate postpartum
Comparison of the frequency of obstetric complications between the MedDiet intervention group and the standard treatment group in women at high risk of developing GDM. Variables for this outcome include: type of delivery, dystocia, lacerations during delivery, preterm or postterm delivery (gestational week at delivery).
From enrollment (gestational week 8-11) to delivery and immediate postpartum

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospital San Carlos, Madrid

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 septembre 2026

Achèvement primaire (Estimé)

31 octobre 2028

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

8 septembre 2026

Première soumission répondant aux critères de contrôle qualité

8 septembre 2026

Première publication (Réel)

14 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 septembre 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PI25_01413
  • 25/902-EC_X (Autre identifiant: Ethics Committee of the Hospital Clinico San Carlos)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

The original protocols of the study will be stored in a locked office in the Department of Endocrinology at our Hospital. De-identified data will be saved on a secure electronic database. Specifically, we will use REDCap® (Vanderbilt University) software, which is known to be a secure, browser-based web application (http://project-redcap.org), for data entry and analysis.

All participant data related to the study, including scales and questionnaires, will be completed in paper form, and will then be recorded and uploaded in the REDCap®Electronic Data Collection Record (eCRD).

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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